Field of the Invention
This invention relates to intravascular procedures and, more particularly, to a method of penetrating an intravascular occlusion to facilitate passage of a device therethrough.
Background Art
In the performance of many intravascular procedures, chronic total or subtotal occlusions may be encountered within arterial passages. Current percutaneous revascularization methods frequently lead to complications, among which are vessel perforation, subintimal space entry, and extensive vascular dissection planes. These complications commonly arise due to the inability to penetrate the proximal occlusive calcified fibrous cap which has a potentially complex surface geometry. Failed fibrous cap penetration may lead to misalignment of guide wires or devices needed to revascularize a target vessel. Misalignment and/or deflection of wires or devices further fosters dissection planes and vessel perforation which may necessitate termination of a revascularization procedure. These occurrences typically result in failure to revascularize the target vessel and may lead to significant patient morbidity or mortality, compartment syndrome, bleeding, critical limb ischemia, limb loss, etc.
Available peripheral vascular tools have not addressed the vascular fibrous cap domain in either a safe or cost-effective fashion. A practical device dedicated to penetration of intravascular occlusions, including at the proximal fibrous cap, and intralumenal wire migration should be simple in design, user friendly, and affordable with regard to both institutional budgets and industry production.